Supercharging the Body's own defenses to fight Hard-to-Treat GIST
NCT ID NCT07647068
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests whether a patient's own immune cells, called tumor-infiltrating lymphocytes (TILs), can be grown in a lab and then given back to fight advanced gastrointestinal stromal tumors (GIST). The study includes people whose GIST has spread, come back, or cannot be removed by surgery and has stopped responding to standard treatments. Participants receive chemotherapy to prepare their body, then the lab-grown TILs along with a drug called aldesleukin to boost the immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous tumor infiltrating lymphocytes (TILs) plus aldesleukin
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced GIST that has stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the treatment may not work for everyone. Side effects from chemotherapy and the immune response can be severe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 59 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Measurable locally advanced, recurrent, or metastatic GIST * Patients with locally advanced disease should be unresectable by conventional surgical approaches * Patients with distant metastatic spread must be refractory to approved standard systemic therapies (such as imatinib and sunitinib) if they are eligible to receive these treatments * Patients must be co-enrolled on the companion protocol Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies (institutional review board \[IRB\] #2024C0043), and have available TIL cultures for therapy * Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible * Greater than or equal to 18 years of age and less than or equal to age 75 * Able to understand and sign the informed consent document * Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1 * Life expectancy of greater than three months * Patients of both genders who are of child-bearing potential must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the treatment * Serology: * Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) * Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be HCV ribonucleic acid (RNA) negative * Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus * Absolute neutrophil count greater than 1000/mm\^3 without the support of filgrastim * White blood cells (WBC) ≥ 3000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin \> 8.0 g/dl * Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ to 3.5 times the upper limit of normal * Serum creatinine ≤ to 1.6 mg/dl and calculated creatinine clearance (Crockcroft-Gault or 24-hour urine creatinine) ≥ 30 mL/min * Total bilirubin ≤ to 2.0 mg/dl, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl * More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo) * Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less Exclusion Criteria: * Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant * Any form of primary immunodeficiency (such as severe combined immunodeficiency disease) * Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities) * Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses * History of major organ autoimmune disease * Concurrent systemic steroid therapy including physiologic replacement dosing of systemic steroids (i.e. prednisone ≤ 10 mg/day or equivalent) as well as topical or inhaled corticosteroids are not allowed * History of severe immediate hypersensitivity reaction to any of the agents used in this study * History of active coronary or ischemic symptoms * Documented left ventricular ejection fraction (LVEF) of less than or equal to 45% * Note: testing is required in patients with: * Age ≥ 65 years old * Clinically significant atrial and or ventricular arrhythmias including but not limited to: * Atrial fibrillation, ventricular tachycardia, second or third degree heart block or have a history of ischemic heart disease, chest pain * Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with: * A prolonged history of cigarette smoking (20 pack \[pk\]/year of smoking within the past 2 years) * Symptoms of respiratory dysfunction * Patients who are receiving any other investigational agents
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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